Specialist QA I - Manufacturing Oversight Job at Planet Group, Boca Raton, FL

T3labHRwR0pzRkZLZ1ZUM2hRL3hnZGdjS1E9PQ==
  • Planet Group
  • Boca Raton, FL

Job Description


The  QA Specialist I - Manufacturing Oversight  performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

Qualifications
ESSENTIALS OF THE JOB:
  • Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
  • Perform Quality Assurance review and approval of Event notifications.
  • Possess and understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
  • Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
  • Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
  • Review and release of Plasma pools to manufacturing.
  • Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
  • Perform review and release of raw materials in LIMS/SAP.
  • Perform audits of Nitrogen receipt process.
  • Assist with quarantining and release of critical systems, equipment, and controlled environments.
  • Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift.
  • Assist in other oversight activities, as needed.
  • Coordinate and perform any additional activities or projects assigned by QA Management.
  • Experience with LIMS and SAP is preferred.

Education Requirements: Bachelor's Degree preferred but can be offset by experience. 

Experience Requirements: 1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry preferred

Job Tags

Permanent employment, Shift work,

Similar Jobs

Vision Truck Line

Truck Drivers CDL Class A Local Home Daily 1150 per week Dedicated Job at Vision Truck Line

 ...Transmission Type: Automatics Drug Test: Hair Test Vision Drivers Enjoy Great Benefits Health, Dental and Vision Long and...  ...lifetime NO FELONIES or MISDEMEANOR EVER - NO EXCEPTION Vision Truck Line LLC is a licensed contract carrier and property broker as... 

Panther Premium Logistics

Truck Driver - Leasing Team CDL-A Contractors Job at Panther Premium Logistics

 ...flexible financing options. We'll support you and your co-driver on your path to truck ownership while providing the resources...  ...in the last 10 years*No experience necessary for straight trucks or cargo vans** All drivers and vehicle owners are independent contractors.

Pacific Aviation

Airline Customer Service Agent - Korean/English Speakers LAX Job at Pacific Aviation

 ...experiences! Were Pacific Aviationthe dedicated team behind seamless airport experiences. As the friendly face passengers rely on, youll be...  ...assistance. Flexibility & Reliability: Available for part-time shifts between 9:00 AM and 1:15 PM, working at least four (4)... 

University of Alabama, Birmingham

Rehab Tech - Inpatient Rehabilitation Services - PRN (803) | University of Alabama, Birmingham Job at University of Alabama, Birmingham

 ...certain professional certifications. Home to nationally designated SCI and TBI Model Systems, provides physical, occupational, speech, recreational, and music therapy. Join our inpatient rehabilitation team and help shape the future of health care in Alabama and beyond.... 

Deseret First Credit Union

Member Service Agent Job at Deseret First Credit Union

 ...up to 12 weeks), you will have the option to work a remote schedule. Summary: The Member Service Agent provides service to members of the credit union by processing...  ...Processes checks Responds to members' e-mail and chat system inquiries Provides credit union products...